Bemfola 75 IU/0.125 ml Bemfola 150 IU/0.25 ml
Contents
1. 2 What you need to know before you use Bemfola You and your partner s fertility should be evaluated before the treatment is Started by a doctor experienced in treating fertility disorders Do not use Bemfola e if you are allergic hypersensitive to Follicle Stimulating Hormone or any of the other ingredients of this medicine listed in section 6 e jf you have a tumour in your hypothalamus or pituitary gland both are parts of the brain e lf you are a woman with large ovaries or sacs of fluids within the ovaries ovarian cysts of unknown origin with unexplained vaginal bleeding with cancer in your ovaries womb or breasts e with a condition that usually makes normal pregnancy impossible such as ovarian failure early menopause or malformed reproductive organs e f you are a man with damaged testicles that cannot be healed Do not use Bemfola if any of the above applies to you If you are not sure talk to your doctor or pharmacist before using this medicine Warnings and precautions Porphyria Tell your doctor before you start treatment if you or any member of your family have porphyria an inability to break down porphyrins that may be passed on from parents to children Tell your doctor straight away if e your skin becomes fragile and easily blistered especially skin that has been frequently in the sun and or e you have stomach arm or leg pain In case of the above events your doc2. can take any time between 5 and 20 days Your doctor will use blood tests and or an ultrasound machine to check when this Is When your eggs are ready you will be given a single injection of 250 micro grams recombinant hCG r hCG an hCG made in a laboratory by a special recombinant DNA technique or 5 000 IU to 10 000 IU of hCG 24 to 48 hours after the last Bemfola injection This gets your eggs ready for collection In other cases your doctor may first stop you from ovulating by using a gonadotropin releasing hormone GnRH agonist or antagonist Then Bemfola is started approximately two weeks after start of agonist treatment The Bemfola and GnRH agonist are then both given until your follicles develop as desired For example after two weeks of GnRH agonist treatment 150 to 225 IU Bemfola is administered for 7 days The dose is then adjusted according to your ovarian response When GnRH antagonist is used it is administered from the 5 or 6 day of Bemfola treatment and continued until ovulation induction Men e The usual dose of Bemfola is 150 IU 0 25 ml together with hCG e You will use these two medicines three times a week for at least 4 months o f you have not responded to treatment after 4 months your doctor may suggest that you continue using these two medicines for at least 18 months If you use more Bemfola than you should The effects of taking too much Bemfola are unknown Nevertheless one could expect Ov
3. of fertilised eggs or embryos placed inside you Miscarriage When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs you are more likely to have a miscarriage than the average woman Blood clotting problems thromboembolic events lf you had in the past or recently blood clots in the leg or in the lung or a heart attack or stroke or if those happened in your family then you might have a higher risk that these problems occur or become worse with Bemfola treatment Men with too much FSH in their blood lf you are a man having too much FSH in your blood can be a sign of damaged testicles Bemfola usually does not work if you have this problem If your doctor decides to try Bemfola treatment to monitor the treatment they may ask you to provide semen for analysis 4 to 6 months after starting treatment Children and adolescents Bemfola is not indicated for use in children and adolescents under 18 years of age Other medicines and Bemfola Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines e f you use Bemfola with other medicines which help ovulation such as hCG or clomiphene citrate this may increase the response of your follicles e f you use Bemfola at the same time as a gonadotropin releasing hormone GnRH agonist or antagonist these medicines reduce your sex hormone levels and stop you ovulating you may need a higher do
4. Package leaflet Information for the user o TINOX rue Bemfola 75 1U 0 125 ml solution for injection in a pre filled pen Bemfola 150 1U 0 25 mi solution for injection in a pre filled pen Bemfola 225 1U 0 375 ml solution for injection in a pre filled pen Bemfola 300 1U 0 50 ml solution for injection in a pre filled pen Bemfola 450 IU 0 75 ml solution for injection in a pre filled pen Follitropin alfa Vv This medicine is subject to additional monitoring This will allow quick identification of new safety information You can help by reporting any side effects you may get See the end of section 4 for how to report side effects Read all of this leaflet carefully before you start using this medicine because it contains important information for you Keep this leaflet You may need to read it again f you have any further questions ask your doctor or pharmacist This medicine has been prescribed for you only Do not pass it on to others It may harm them even if their symptoms are the same as yours lf you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet See section 4 What is in this leaflet 1 What Bemfola is and what it is used for 2 What you need to know before you use Bemfola 3 How to use Bemfola 4 Possible side effects 5 How to store Bemfola 6 Contents of the pack and other information 1 What Bemfola is a
5. arian Hyper Stimulation Syndrome OHSS to occur which is described in section 4 However the OHSS will only occur if hCG is also administered see section 2 OHSS If you forget to use Bemfola lf you forget to use Bemfola do not take a double dose to make up for a forgotten dose Please talk to your doctor as soon as you notice that you forgot a dose Bemfola_Englisch lf you have any further questions on the use of this medicine ask your doctor or pharmacist 4 Possible side effects Like all medicines Bemfola can cause side effects although not everybody gets them Important side effects Serious side effects in women e Lower abdominal pain together with nausea or vomiting may be the symptoms of Ovarian Hyper Stimulation Syndrome OHSS This may indicate that the ovaries over reacted to the treatment and that large ovarian cysts developed see also section 2 Take special care with Bemfola This side effect is common may affect up to 1 in 10 people OHSS may become severe with clearly enlarged ovaries decreased urine production weight gain difficulty in breathing and or possible fluid accumulation in your stomach or chest This side effect is uncommon may affect up to 1 in 100 people Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely may affect up to 1 in 1000 people serious blood clotting complications thromboembolic events independent of OHSS may be found very rarely ma
6. ere to inject e g tummy front of thigh To minimise skin irritation select a different injection site each day Clean the injection site with the alcohol swab Fold the skin lightly and insert the injection needle completely at a 45 to 90 angle using a dart like motion Caution Do not push the dosage knob while inserting injection needle Push the dosage knob until the stop Note Push slowly but continuously the dose bar disappears End of the injection The dose bar has disappeared completely behind the display window the display window shows the injected dose Wait for 5 seconds then pull out the injection needle After the withdrawal of the needle clean the skin with an alcohol swab using a circular motion Replace the outer needle cap carefully Throw away the packaging box inner needle cap peel tab alcohol swab and the instructions for use in the household waste Return used pre filled pens to your pharmacist Bemfola_Englisch
7. in the first 7 days of your menstrual cycle If you do not have periods you can start using the medicine on any convenient day The usual starting dose of Bemfola is 75 to 150 IU 0 12 to 0 25 ml each day Your dose of Bemfola may be increased every 7 or every 14 days by 37 5 to 75 U until you get the desired response The maximum daily dose of Bemfola is usually not higher than 225 IU 0 375 ml When you get the desired response you will be given a single injection of 290 micrograms of recombinant hCG r hCG an hCG made in a laboratory by a special DNA technique or 5 000 to 10 000 IU of hCG 24 to 48 hours after your last Bemfola injection The best time to have sex is on the day of the hCG injection and the day after lf your doctor cannot see a desired response after 4 weeks that treatment cycle with Bemfola should be stopped For the following treatment cycle your doctor will give you a higher starting dose of Bemfola than before lf your body responds too strongly your treatment will be stopped and you will not be given any hCG see section 2 OHSS For the following cycle your doctor will give you a lower dose of Bemfola than before If you are not ovulating having no periods and have been diagnosed with very low levels of FSH and LH hormones e The usual starting dose of Bemfola is 75 to 150 IU 0 12 to 0 25 ml together with 75 IU 0 12 ml of lutropin alfa e You will use these two medicines each day for up to f
8. injection in a pre filled pen e Bemfola is supplied in packs with 1 pre filled pen 1 disposable needle and 1 alcohol swab Marketing Authorisation Holder and Manufacturer FINOX Biotech AG Garten 71 FL 9496 Balzers United Kingdom tel 0845 073 8735 800 3466 9246 FinoxEU pilglobal com Ireland Malta tel 800 3466 9246 FinoxEU pilglobal com This leaflet was last revised in March 2014 Detailed information on this medicine is available on the European Medicines Agency web site http www ema europa eu This leaflet is available in all EU EEA languages on the European Medicines Agency website Bemfola 75 1U 0 125 ml pre filled pen Bemfola 150 1U 0 25 ml pre filled pen Bemfola 225 1U 0 375 ml pre filled pen Bemfola 300 1U 0 50 ml pre filled pen Bemfola 450 1U 0 75 ml pre filled pen Instructions for Use CONTENTS 1 How to use the Bemfola pre filled pen 2 Before you start using your pre filled pen 3 Getting your pre filled pen ready for injection 4 Setting the dose 5 Injecting the dose 6 After the injection 1 How to use the Bemfola pre filled pen e Before starting to use your pre filled pen please read these instructions the whole way through first e Only use this pen for you do not let anyone else use it e The numbers on the dose display are measured in International Units or IU Your doctor will have told you how many IU to inject each day o Your doctor pharmacist will tell you how many Bemfola pen
9. ive weeks e Your dose of Bemfola may be increased every 7 or every 14 days by 37 5 to 75 U until you get the desired response When you get the desired response you will be given a single injection of 290 micrograms of recombinant hCG r hCG an hCG made in a laboratory by a special DNA technique or 5 000 to 10 000 IU of hCG 24 to 48 hours after your last injections of Bemfola and lutropin alfa The best time to have sex is on the day of the hCG injection and the day after Alternatively intrauterine insemination may be performed by placing the sperm into the womb cavity lf your doctor cannot see a response after 5 weeks that treatment cycle with Bemfola should be stopped For the following cycle your doctor will give you a higher starting dose of Bemfola than before lf your body responds too strongly your treatment with Bemfola will be Stopped and you will not be given any hCG see section 2 OHSS For the following cycle your doctor will give you a lower dose of Bemfola than before If you need to develop several eggs for collection prior to any assisted reproductive technology e The usual starting dose of Bemfola is 150 to 225 IU 0 25 to 0 37 ml each day from day 2 or 3 of your treatment cycle e Bemfola dose may be increased depending on your response The maximum daily dose is 450 IU 0 75 ml Treatment is continued until your eggs have developed to a desired point This usually takes about 10 days but
10. nd what it is used for What Bemfola is This medicine contains the active substance follitropin alfa which is almost identical to a natural hormone produced by your body called follicle stimulating hormone FSH FSH is a gonadotropin a type of hormone that plays an important role in human fertility and reproduction In women FSH is needed for the growth and development of the sacs follicles in the ovaries that contain the egg cells In men FSH is needed for the production of sperm What Bemfola is used for In adult women Bemfola is used e to help release an egg from the ovary ovulation in women that cannot ovulate and that did not respond to treatment with a medicine called clomiphene citrate e together with another medicine called lutropin alfa Luteinising Hormone or LH to help release egg from the ovary ovulation in women that are not ovulating because their body is producing very little gonadotropins FSH and LH e to help develop several follicles each containing an egg in women undergoing assisted reproductive technology procedures procedures that may help you to become pregnant such as in vitro fertilisation gamete intra fallopian transfer or zygote intra fallopian transfer In adult men Bemfola is used e together with another medicine called human Chorionic Gonadotropin hCG to help produce sperm in men that are infertile due to a low level of certain hormones
11. notice any visible signs of deterioration if the liquid contains particles or is not clear Once opened the medicine should be injected immediately Do not throw any medicines away via wastewater or household waste Ask your pharmacist how to dispose of medicines you no longer use These measures will help to protect the environment 6 Contents of the pack and other information What Bemfola contains e The active substance is follitropin alfa e Bemfola 75 IU 0 125 ml Each cartridge contains 75 IU equivalent to 5 5 micrograms follitropin alfa in 0 125 ml solution Bemfola 150 1U 0 25 ml Each cartridge contains 150 IU equivalent to 11 micrograms follitropin alfa in 0 25 ml solution Bemfola 225 U 0 375 ml Each cartridge contains 225 IU equivalent to 16 5 micrograms follitropin alfa in 0 375 ml solution Bemfola 300 IU 0 50 ml Each cartridge contains 300 IU equivalent to 22 micrograms follitropin alfa in 0 50 ml solution Bemfola 450 IU 0 75 ml Each cartridge contains 450 IU equivalent to 33 micrograms follitropin alfa in 0 75 mL solution Each mL of the solution contains 600 IU equivalent to 44 micrograms follitropin alfa e The other ingredients are poloxamer 188 sucrose methionine disodium hydrogen phosphate dihydrate sodium dihydrogen phosphate dihydrate phosphoric acid and water for injections What Bemfola looks like and contents of the pack e Bemfola is presented as a clear colourless liquid for
12. s you need to use for your complete treatment course e Give yourself the injection at the same time each day 2 Before you start using your pre filled pen 2 1 Wash your hands e itis important that your hands and the things you use to get your pen ready are as clean as possible 2 2 Find a clean area e A good place is a clean table or surface 3 Getting your pre filled pen ready for injection Perform the injection every day at the same time y Take the pen out of the fridge 5 to 10 minutes before using it Note Please check that the medicine is not frozen Remove the peel tab from the injection needle Attach the injection needle until it is securely fixed Caution Do not push the dosage knob while clicking on the injection needle Remove the outer and inner needle protection caps Hold the pen with the needle pointing upright Tap the pen slightly in order to make eventual air bubbles rise Hold the pen with needle pointing Upright Push the dosage knob until the stop Note The activation bar disappears and a small amount of liquid splashes out lf a small amount of liquid is not splashed out the pen should not be used Turn the dosage knob until the desired dose dose bar is set in the display window Note The pen is now ready for injection Caution Do not push the dosage knob 5 Injecting the dose Immediately inject the solution Your doctor or nurse will have already advised you wh
13. se of Bemfola to produce follicles Pregnancy and breast feeding Do not use Bemfola if you are pregnant or breast feeding Driving and using machines It is not expected that this medicine will affect your ability to drive and use machines Bemfola contains sodium Bemfola contains less than 1 mmol sodium 23 mg per dose therefore it is considered essentially sodium free 3 How to use Bemfola Always use this medicine exactly as your doctor has told you Check with your doctor or pharmacist if you are not sure ak this medicine e Bemfola is intended to be given by injection just under the skin subcutane ously The pre filled pen is used only once then thrown away The solution Should not be administered if it contains particles or is not clear e The first injection of Bemfola should be given under supervision of your doctor e Your doctor or nurse will show you how to use the Bemfola pre filled pen to inject the medicine e f you administer Bemfola to yourself please carefully read and follow the Instructions for Use These instructions can be found at the end of the package leaflet How much to use Your doctor will decide how much medicine you will take and how often The doses described below are stated in International Units IU and millilitres ml Women If you are not ovulating and have irregular or no periods Bemfola is usually given every day If you have irregular periods start using Bemfola with
14. th difficulty in breathing may occur These reactions can sometimes be Serious e Your asthma may get worse Reporting of side effects lf you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet You can also report side effects directly see details below By reporting side effects you can help provide more information on the safety of this medicine United Kingdom Yellow Card Scheme Website www mhra gov uk yellowcard Ireland IMB Pharmacovigilance Earlsfort Terrace IRL Dublin 2 Tel 353 1 6764971 Fax 353 1 6762517 Website www imb ie e mail imbpharmacovigilance imb ie Malta ADR Reporting The Medicines Authority Post Licensing Directorate 203 Level 3 Rue D Argens GZR 1368 Gzira Website www medicinesauthority gov mt e mail postlicensing medicinesauthority gov mt 5 How to store Bemfola Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the pen label or carton after EXP The expiry date refers to the last day of that month Store in a refrigerator 2 C 8 C Do not freeze Within its shelf life the unopened product may be stored at or below 25 C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months Store in the original package in order to protect from light Do not use this medicine if you
15. tor may recommend that you stop treatment Ovarian Hyper Stimulation Syndrome OHSS lf you are a woman this medicine increases your risk of developing OHSS This is when your follicles develop too much and become large cysts If you get lower abdominal pain gain any weight rapidly feel sick or are vomiting or if you have difficulty in breathing talk to your doctor straight away who might ask you to stop using this medicine see section 4 In case you are not ovulating and if the recommended dose and schedule of administration are adhered to the occurrence of OHSS is less likely Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation containing human Chorionic Gonadotropin hCG is administered If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days Multiple pregnancy When using Bemfola you have a higher risk of being pregnant with more than one child at the same time multiple pregnancy mostly twins than if you conceived naturally Multiple pregnancy may lead to medical complications for you and your babies You can reduce the risk of multiple pregnancy by using the right dose of Bemfola at the right times When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age the quality and the number
16. y affect up to 1 in 10 000 people This could cause chest pain breathlessness stroke or heart attack see also section 2 Take special care with Bemfola e Allergic reactions such as rash red skin hives swelling of your face with difficulty breathing can sometimes be serious This side effect is very rare may affect up to 1 in 10 000 people lf you notice any of the above listed side effects you should immediately contact your doctor who might ask you to stop using Bemfola Other side effects in women Very common may affect more than 1 in 10 people e Sacs of fluid within the ovaries ovarian cysts e Headache e Local reactions at the injection site such as pain redness bruising swelling and or irritation Common may affect up to 1 in 10 people e Abdominal pain e Feeling sick vomiting diarrhoea abdominal cramps and bloating e Allergic reactions such as rash red skin hives swelling of your face with difficulty breathing may occur These reactions can sometimes be serious e Your asthma may get worse Other side effects in men Very common may affect more than 1 in 10 people e Local reactions at the injection site such as pain redness bruising swelling and or irritation Common may affect up to 1 in 10 people e Swelling of the veins above and behind the testicles varicocele e Breast development acne or weight gain e Allergic reactions such as rash red skin hives swelling of your face wi
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